NCT03325920

Validation of a Diagnostic Method for Quantification of Sleep Bruxism

Validation of a Diagnostic Method for Quantification and Monitoring of Sleep Bruxism

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Heinrich-Heine University, Duesseldorf · Academic / Other
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study aims to validate a new diagnostic method for quantification and monitoring of sleep bruxism.

Detailed description

Sleep bruxism has characteristically been defined by the American Academy of Sleep Medicine as 'an oral activity characterized by grinding or clenching of the teeth during sleep, usually associated with sleep arousals'. For sleep bruxism diagnosis, to date the polysomnographic recordings represent the highest standard for sleep bruxism diagnosis, but they are concomitantly associated with disadvantages which include technical complexity, limited availability, and the fact that they are time-consuming and cost-intensive. Recently, a prototype of a diagnostic plate has been developed which allows a fully-automatic, computer-based quantification of abrasion thereupon for the assessment of sleep bruxism activity. The results of the pilot study were promising, and therefore, the aim of the present study is to refine and validate this new diagnostic method for quantification and monitoring of sleep bruxism.

Conditions

• Sleep Bruxism
• Diagnosis

Interventions

Type	Name	Description
DEVICE	DIABRUX	All participants receive an individually fabricated diagnostic plate, viz the DIABRUX, for the upper or lower jaw to be worn for five consecutive nights. After use a newly developed analyzing software quantifies the abrasion on the diagnostic plate, thus resulting in a score, viz the Pixel score. This represents a quantitative measure of sleep bruxism activity.

Timeline

• Start date: 2019-05-20
• Primary completion: 2020-07-31
• Completion: 2020-07-31
• First posted: 2017-10-30
• Last updated: 2021-03-11

Locations

1 site across 1 country: Germany